Process Validation of a Multivalent Bacterial Vaccine

Author(s):  
Narahari Pujar ◽  
Ann Lee ◽  
Wayne Herber ◽  
Michael Dekleva ◽  
P Yegneswaran ◽  
...  
Polymers ◽  
2021 ◽  
Vol 13 (4) ◽  
pp. 650
Author(s):  
Jose Maria Alonso ◽  
Jon Andrade del Olmo ◽  
Raul Perez Gonzalez ◽  
Virginia Saez-Martinez

The transfer of some innovative technologies from the laboratory to industrial scale is many times not taken into account in the design and development of some functional materials such as hydrogels to be applied in the biomedical field. There is a lack of knowledge in the scientific field where many aspects of scaling to an industrial process are ignored, and products cannot reach the market. Injectable hydrogels are a good example that we have used in our research to show the different steps needed to follow to get a product in the market based on them. From synthesis and process validation to characterization techniques used and assays performed to ensure the safety and efficacy of the product, following regulation, several well-defined protocols must be adopted. Therefore, this paper summarized all these aspects due to the lack of knowledge that exists about the industrialization of injectable products with the great importance that it entails, and it is intended to serve as a guide on this area to non-initiated scientists. More concretely, in this work, the characteristics and requirements for the development of injectable hydrogels from the laboratory to industrial scale is presented in terms of (i) synthesis techniques employed to obtain injectable hydrogels with tunable desired properties, (ii) the most common characterization techniques to characterize hydrogels, and (iii) the necessary safety and efficacy assays and protocols to industrialize and commercialize injectable hydrogels from the regulatory point of view. Finally, this review also mentioned and explained a real example of the development of a natural hyaluronic acid hydrogel that reached the market as an injectable product.


Author(s):  
Ajay Babu Pazhayattil ◽  
Naheed Sayeed-Desta ◽  
Emilija Fredro-Kumbaradzi ◽  
Jordan Collins

1971 ◽  
Vol 132 (1) ◽  
pp. 79-92 ◽  
Author(s):  
Junius M. Clark ◽  
Leon Weiss

1909 ◽  
Vol 9 (2) ◽  
pp. 181-219 ◽  
Author(s):  
L. Noon

The following experiments constitute an attempt to follow out in detail the stages by which immunity is established, in the course of a generalised bacterial infection (Pseudotuberculosis of rabbits). Two aspects of immunity are considered, firstly the presence, in the circulating fluids, of specific antibacterial substances, and secondly the power of rapidly producing such substances in answer to the specific stimulus. That is to say, attention is directed, not only to the quantity of specific antibodies present on any day of the disease, but also to the response which the animal can make to various doses of bacterial vaccine. For the immune animal is both more vigorous and more sensitive than the normal, in its reaction to a renewed dose of poison (Wassermann and Citron, 1905). Naturally the facts established with regard to one disease only, cannot be predicated at once of other diseases, in other animals. Still it is hoped that the systematic study of one disease may give some help in coordinating the large but somewhat disjointed mass of clinical observation which is already available.


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